CoCo-20: a Longitudinal Follow-up Study of the French Paediatric Population During and After the Coronavirus Pandemic COVID-19

NCT04498416 | Completed

• 1 other identifier: 20-HPNCL-05
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations. After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems. The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term

Conditions

Mental Health Disorder

Outcome Measures

Primary Outcomes (1)

• diagnosis of possible psychological and psychiatric difficulties at baseline

  measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments :

  at baseline Day 0

Secondary Outcomes (6)

• follow up of psychological and psychiatric difficulties at V2

  at one month after baseline

• follow up of psychological and psychiatric difficulties at V3

  at one week after the end of the containment

• follow up of psychological and psychiatric difficulties at V4

  at one month after the end of the containment

• impact of traumatic history prior to confinement

  at one week after baseline and at one month after the end of the containment

• impact of other previous psychiatric disorders

  at one month after baseline and at one month after the end of the containment

Study Arms (3)

Group 1 Post-Traumatic Stress Disorder (PTSD)

children with an identified traumatic history

Diagnostic Test: Quantitative and qualitative assessments of mental health

Group 2 Pathology

children with psychological follow-up treatment for a psychiatric disorder, without traumatic history;

Diagnostic Test: Quantitative and qualitative assessments of mental health

Group 3 Control

children without traumatic experience and without psychiatric or psychological follow-up treatment.

Diagnostic Test: Quantitative and qualitative assessments of mental health

Interventions

Quantitative and qualitative assessments of mental health DIAGNOSTIC_TEST

Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale

Group 1 Post-Traumatic Stress Disorder (PTSD); Group 2 Pathology; Group 3 Control

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Group 1 (PTSD): children with an identified traumatic history; Group 2 (Pathology): children with psychological follow-up treatment for a psychiatric disorder, without traumatic history; Group 3 (Control): children without traumatic experience and without psychiatric or psychological follow-up treatment.

You may qualify if:

• Children affected by the Coronavirus disease 2019 (Covid-19) pandemic;
• Affiliated with a social security scheme;
• Having a good command of the French language (French);
• Children whose parents have accepted participation in the study (collection of informed consents).

You may not qualify if:

• Children and/or young adults with a psychotic disorder or autism spectrum disorder;
• Children and/or young adults with an average intellectual disability (\< to 50);
• Person deprived of liberty by judicial or administrative decision1;

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Related Publications (1)

• Gindt M, Fernandez A, Richez A, Nachon O, Battista M, Askenazy F. CoCo20 protocol: a pilot longitudinal follow-up study about the psychiatric outcomes in a paediatric population and their families during and after the stay-at-home related to coronavirus pandemic (COVID-19). BMJ Open. 2021 Apr 8;11(4):e044667. doi: 10.1136/bmjopen-2020-044667.

  PMID: 34270445 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Florence Gittard-Askenazy, Pr

  Hôpitaux Pédiatriques de Nice CHU-LENVAL

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: April 27, 2020
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-01

Locations

FR (1)